PRINTER'S NO. 703
No. 647 Session of 2001
INTRODUCED BY DeLUCA, BEBKO-JONES, BELARDI, BELFANTI, BISHOP, CAPPABIANCA, M. COHEN, CORRIGAN, COSTA, CURRY, FRANKEL, FREEMAN, GEORGE, HARHAI, HENNESSEY, JAMES, JOSEPHS, LAUGHLIN, MANDERINO, MICHLOVIC, OLIVER, ORIE, PISTELLA, READSHAW, SCRIMENTI, SOLOBAY, STABACK, STEELMAN, STURLA, SURRA, TIGUE, TRAVAGLIO, TRELLO, TRICH, VEON, WALKO, C. WILLIAMS, WOJNAROSKI, YEWCIC AND YOUNGBLOOD, FEBRUARY 12, 2001
REFERRED TO COMMITTEE ON INSURANCE, FEBRUARY 12, 2001
AN ACT 1 Amending the act of May 17, 1921 (P.L.682, No.284), entitled "An 2 act relating to insurance; amending, revising, and 3 consolidating the law providing for the incorporation of 4 insurance companies, and the regulation, supervision, and 5 protection of home and foreign insurance companies, Lloyds 6 associations, reciprocal and inter-insurance exchanges, and 7 fire insurance rating bureaus, and the regulation and 8 supervision of insurance carried by such companies, 9 associations, and exchanges, including insurance carried by 10 the State Workmen's Insurance Fund; providing penalties; and 11 repealing existing laws," providing for health insurance 12 coverage for cancer clinical trials costs. 13 The General Assembly of the Commonwealth of Pennsylvania 14 hereby enacts as follows: 15 Section 1. The act of May 17, 1921 (P.L.682, No.284), known 16 as The Insurance Company Law of 1921, is amended by adding a 17 section to read: 18 Section 631.1. Reimbursement for Clinical Trials.--(a) Any 19 other provision of law notwithstanding, any individual or group 20 health, sickness and accident insurance policy, group health
1 insurance plans/policies, and all other forms of 2 managed/capitated care plans/policies or subscriber contract or 3 certificate issued by any entity subject to 40 Pa.C.S. Ch. 61 4 (relating to hospital plan corporations) or 63 (relating to 5 professional health services plan corporations) or the act of 6 December 29, 1972 (P.L.1701, No.364), known as the "Health 7 Maintenance Organization Act," the act of December 14, 1992 8 (P.L.835, No.134), known as the "Fraternal Benefit Societies 9 Code," or this act providing hospital or medical/surgical 10 coverage shall provide coverage for patient costs incurred 11 during participation in clinical trials for treatment studies on 12 cancer, including ovarian cancer trials, under any such policy, 13 contract or plan delivered, issued for delivery, or renewed in 14 this Commonwealth on and after July 1, 1999. The benefits 15 specified in this section may be provided through a combination 16 of policies, contracts, certificates or riders, including major 17 medical contracts. 18 (b) The reimbursement for patient costs incurred during 19 participation in clinical trials for treatment studies on cancer 20 shall be determined in the same manner as reimbursement is 21 determined for other medical and surgical procedures. Such 22 coverage shall have durational limits, dollar limits, 23 deductibles, copayments and coinsurance factors that are no less 24 favorable than for physical illness generally. 25 (c) Coverage for patient costs incurred during clinical 26 trials for treatment studies on cancer shall be provided if the 27 treatment is being conducted in a Phase II, Phase III or Phase 28 IV clinical trial. Such treatment may, however, be provided on a 29 case-by-case basis if the treatment is being provided in a Phase 30 I clinical trial. 20010H0647B0703 - 2 -
1 (d) The treatment described in subsection (c) shall be 2 provided by a clinical trial approved by one of the following: 3 (1) The National Cancer Institute. 4 (2) An NCI cooperative group or an NCI center. 5 (3) The FDA in the form of an investigational new drug 6 application. 7 (4) The United States Department of Veterans Affairs. 8 (5) An institutional review board of an institution in this 9 Commonwealth that has a multiple project assurance contract 10 approved by the Office of Protection from Research Risks of the 11 NCI. 12 (e) The facility and personnel providing the treatment shall 13 be capable of doing so by virtue of their experience, training 14 and expertise. 15 (f) Coverage under this section shall apply only if: 16 (1) There is no clearly superior, noninvestigational 17 treatment alternative. 18 (2) The available clinical or preclinical data provide a 19 reasonable expectation that the treatment will be at least as 20 effective as the noninvestigational alternative. 21 (3) The member and the physician or health care provider who 22 provides services to the member under the insurance policy, 23 subscriber contract or health care plan conclude that the 24 member's participation in the clinical trial would be 25 appropriate, pursuant to procedures established by the insurer, 26 corporation or health maintenance organization and as disclosed 27 in the policy and evidence of coverage. 28 (g) This section shall not apply to short-term travel, 29 accident-only, limited or specified disease policies or 30 contracts designed for issuance to persons eligible for coverage 20010H0647B0703 - 3 -
1 under Title XVIII of the Social Security Act (49 Stat. 620, 42 2 U.S.C. § 301 et seq.), known as Medicare, or any other similar 3 coverage under State or governmental plans or to short-term 4 nonrenewable policies of not more than six months' duration. 5 (h) Definitions.--As used in this section, the following 6 words and phrases shall have the meanings given to them in this 7 subsection: 8 (1) "Cooperative group" means a formal network of facilities 9 that collaborate on research projects and have an established 10 NIH-approved peer review program operating within the group. The 11 term includes: 12 (i) The National Cancer Institute Clinical Cooperative 13 Group. 14 (ii) The National Cancer Institute Community Clinical 15 Oncology Program. 16 (2) "FDA" means the United States Food and Drug 17 Administration. 18 (3) "Member" means a policyholder, subscriber, insured or 19 certificate holder or a covered dependent of a policyholder, 20 subscriber, insured or certificate holder. 21 (4) "Multiple project assurance contract" means a contract 22 between an institution and the Department of Health and Human 23 Services (DHHS) (20 U.S.C. § 3508) that defines the relationship 24 of the institution to the Department of Health and Human 25 Services and sets out the responsibilities of the institution 26 and the procedures that will be used by the institution to 27 protect human subjects. 28 (5) "NCI" means the National Cancer Institute. 29 (6) "NIH" means the National Institutes of Health. 30 (7) "Patient cost" means the cost of a medically necessary 20010H0647B0703 - 4 -
1 health care service that is incurred as a result of the 2 treatment being provided to the member for purposes of a 3 clinical trial. The term does not include: 4 (i) The cost of nonhealth care services that a patient may 5 be required to receive as a result of the treatment being 6 provided for purposes of a clinical trial. 7 (ii) Costs associated with managing the research associated 8 with the clinical trial. 9 (iii) The cost of the investigational drug or device. 10 Section 2. This act shall take effect immediately. A31L40MSP/20010H0647B0703 - 5 -